Drug
Scopolamine
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Mydriasis | 200 | 58.9 | 61.0 | signal |
| 2 | Application Site Irritation | 72 | 21.6 | 21.9 | signal |
| 3 | Application Site Rash | 67 | 18.1 | 18.3 | signal |
| 4 | Application Site Pruritus | 86 | 14.1 | 14.3 | signal |
| 5 | Application Site Erythema | 98 | 13.9 | 14.1 | signal |
| 6 | Salivary Hypersecretion | 35 | 13.1 | 13.1 | signal |
| 7 | Product Adhesion Issue | 106 | 11.1 | 11.3 | signal |
| 8 | Disorientation | 115 | 10.8 | 11.0 | signal |
| 9 | Aspiration | 29 | 10.0 | 10.0 | signal |
| 10 | Dry Mouth | 205 | 9.4 | 9.7 | signal |
| 11 | Application Site Pain | 52 | 8.8 | 8.9 | signal |
| 12 | Withdrawal Syndrome | 99 | 8.7 | 8.9 | signal |
| 13 | Hallucination | 173 | 8.6 | 8.8 | signal |
| 14 | Supraventricular Tachycardia | 20 | 7.8 | 7.8 | signal |
| 15 | Drug Ineffective For Unapproved Indication | 116 | 7.7 | 7.9 | signal |
| 16 | Vision Blurred | 278 | 7.6 | 7.9 | signal |
| 17 | Incorrect Drug Administration Duration | 58 | 7.6 | 7.6 | signal |
| 18 | Therapeutic Response Unexpected | 88 | 7.3 | 7.4 | signal |
| 19 | Pneumonia Aspiration | 47 | 7.0 | 7.1 | signal |
| 20 | Neutrophil Count Increased | 19 | 6.9 | 6.9 | signal |
| 21 | Vertigo | 110 | 6.7 | 6.8 | signal |
| 22 | Hiatus Hernia | 23 | 6.6 | 6.6 | signal |
| 23 | Delirium | 61 | 6.6 | 6.6 | signal |
| 24 | Dermatitis Contact | 20 | 6.6 | 6.6 | signal |
| 25 | Impaired Driving Ability | 20 | 6.5 | 6.6 | signal |
| 26 | Swollen Tongue | 54 | 6.4 | 6.5 | signal |
| 27 | Dry Throat | 17 | 6.2 | 6.2 | signal |
| 28 | Hallucination, Visual | 35 | 6.2 | 6.2 | signal |
| 29 | Atelectasis | 16 | 6.1 | 6.2 | signal |
| 30 | Hyperlipidaemia | 19 | 5.9 | 5.9 | signal |
| 31 | Lymphocyte Count Decreased | 28 | 5.9 | 5.9 | signal |
| 32 | Acute Respiratory Failure | 30 | 5.8 | 5.9 | signal |
| 33 | Metastases To Central Nervous System | 20 | 5.8 | 5.8 | signal |
| 34 | Ileus | 19 | 5.7 | 5.8 | signal |
| 35 | Akathisia | 21 | 5.7 | 5.7 | signal |
| 36 | Confusional State | 240 | 5.5 | 5.7 | signal |
| 37 | Hypothermia | 15 | 5.5 | 5.5 | signal |
| 38 | Small Intestinal Obstruction | 18 | 5.5 | 5.5 | signal |
| 39 | Photophobia | 27 | 5.4 | 5.4 | signal |
| 40 | Device Related Infection | 22 | 5.3 | 5.3 | signal |
| 41 | Retching | 30 | 5.2 | 5.3 | signal |
| 42 | Arteriosclerosis | 13 | 5.1 | 5.1 | signal |
| 43 | Blood Urea Increased | 23 | 5.1 | 5.1 | signal |
| 44 | Neuroleptic Malignant Syndrome | 16 | 5.0 | 5.0 | signal |
| 45 | Product Quality Issue | 180 | 5.0 | 5.1 | signal |
| 46 | Blood Calcium Decreased | 15 | 4.9 | 5.0 | signal |
| 47 | Pneumothorax | 21 | 4.9 | 4.9 | signal |
| 48 | Coeliac Disease | 13 | 4.9 | 4.9 | signal |
| 49 | Unresponsive To Stimuli | 34 | 4.9 | 4.9 | signal |
| 50 | Dysphonia | 77 | 4.9 | 5.0 | signal |
| 51 | Cytokine Release Syndrome | 25 | 4.9 | 4.9 | signal |
| 52 | Diplopia | 34 | 4.9 | 4.9 | signal |
| 53 | Drug Administered At Inappropriate Site | 14 | 4.9 | 4.9 | signal |
| 54 | Bedridden | 17 | 4.8 | 4.8 | signal |
| 55 | Urinary Retention | 43 | 4.8 | 4.8 | signal |
| 56 | Fear | 35 | 4.8 | 4.8 | signal |
| 57 | Angioedema | 57 | 4.8 | 4.8 | signal |
| 58 | Muscle Spasticity | 16 | 4.8 | 4.8 | signal |
| 59 | Agitation | 93 | 4.7 | 4.8 | signal |
| 60 | Bursitis | 15 | 4.6 | 4.6 | signal |
| 61 | Coordination Abnormal | 17 | 4.5 | 4.5 | signal |
| 62 | Speech Disorder | 63 | 4.5 | 4.5 | signal |
| 63 | Restlessness | 44 | 4.5 | 4.5 | signal |
| 64 | Hypoxia | 42 | 4.5 | 4.5 | signal |
| 65 | Bacteraemia | 14 | 4.4 | 4.4 | signal |
| 66 | Mental Status Changes | 33 | 4.4 | 4.4 | signal |
| 67 | Tachypnoea | 16 | 4.4 | 4.4 | signal |
| 68 | Impaired Gastric Emptying | 15 | 4.4 | 4.4 | signal |
| 69 | Intestinal Obstruction | 44 | 4.4 | 4.4 | signal |
| 70 | Deformity | 11 | 4.4 | 4.4 | signal |
| 71 | Paranoia | 20 | 4.3 | 4.3 | signal |
| 72 | Hypercholesterolaemia | 11 | 4.3 | 4.3 | signal |
| 73 | Seasonal Allergy | 16 | 4.2 | 4.2 | signal |
| 74 | Clostridium Difficile Colitis | 12 | 4.2 | 4.2 | signal |
| 75 | Aphasia | 34 | 4.2 | 4.2 | signal |
| 76 | Ascites | 33 | 4.2 | 4.2 | signal |
| 77 | Impaired Work Ability | 24 | 4.2 | 4.2 | signal |
| 78 | Septic Shock | 48 | 4.1 | 4.2 | signal |
| 79 | Dyskinesia | 45 | 4.1 | 4.2 | signal |
| 80 | Scar | 19 | 4.1 | 4.1 | signal |
| 81 | Immunodeficiency | 16 | 4.0 | 4.0 | signal |
| 82 | Eyelid Ptosis | 11 | 4.0 | 4.0 | signal |
| 83 | Choking | 21 | 4.0 | 4.0 | signal |
| 84 | Swelling Face | 70 | 4.0 | 4.0 | signal |
| 85 | Hallucination, Auditory | 17 | 4.0 | 4.0 | signal |
| 86 | Balance Disorder | 92 | 4.0 | 4.0 | signal |
| 87 | Activities Of Daily Living Impaired | 21 | 3.9 | 3.9 | signal |
| 88 | Vomiting | 490 | 3.9 | 4.2 | signal |
| 89 | Delusion | 16 | 3.8 | 3.9 | signal |
| 90 | Dysuria | 38 | 3.8 | 3.9 | signal |
| 91 | Amnesia | 66 | 3.8 | 3.8 | signal |
| 92 | Aphonia | 14 | 3.7 | 3.7 | signal |
| 93 | Abasia | 25 | 3.7 | 3.7 | signal |
| 94 | Upper Respiratory Tract Infection | 46 | 3.7 | 3.7 | signal |
| 95 | Malnutrition | 11 | 3.7 | 3.7 | signal |
| 96 | Dehydration | 130 | 3.6 | 3.7 | signal |
| 97 | Mitral Valve Incompetence | 11 | 3.6 | 3.6 | signal |
| 98 | Multi-organ Failure | 17 | 3.6 | 3.6 | signal |
| 99 | Tachycardia | 86 | 3.6 | 3.6 | signal |
| 100 | Intervertebral Disc Degeneration | 9 | 3.6 | 3.6 | signal |
| 101 | Disturbance In Attention | 52 | 3.6 | 3.6 | signal |
| 102 | Sedation | 25 | 3.6 | 3.6 | signal |
| 103 | Colitis | 36 | 3.6 | 3.6 | signal |
| 104 | Cholelithiasis | 31 | 3.5 | 3.5 | signal |
| 105 | Febrile Neutropenia | 62 | 3.5 | 3.5 | signal |
| 106 | Prescribed Overdose | 18 | 3.5 | 3.5 | signal |
| 107 | Abnormal Behaviour | 37 | 3.5 | 3.5 | signal |
| 108 | Parkinsonism | 9 | 3.4 | 3.4 | signal |
| 109 | Sinus Tachycardia | 13 | 3.4 | 3.4 | signal |
| 110 | Psychotic Disorder | 27 | 3.4 | 3.4 | signal |
| 111 | Disability | 18 | 3.4 | 3.4 | signal |
| 112 | Respiratory Distress | 25 | 3.4 | 3.4 | signal |
| 113 | Dysphagia | 85 | 3.3 | 3.4 | signal |
| 114 | Dizziness | 447 | 3.3 | 3.5 | signal |
| 115 | Stevens-johnson Syndrome | 20 | 3.3 | 3.3 | signal |
| 116 | Hypertensive Crisis | 10 | 3.3 | 3.3 | signal |
| 117 | Wrong Technique In Drug Usage Process | 33 | 3.3 | 3.3 | signal |
| 118 | Hypokalaemia | 41 | 3.3 | 3.3 | signal |
| 119 | Head Injury | 28 | 3.3 | 3.3 | signal |
| 120 | Pleural Effusion | 54 | 3.3 | 3.3 | signal |
| 121 | Nausea | 698 | 3.3 | 3.6 | signal |
| 122 | Product Complaint | 22 | 3.3 | 3.3 | signal |
| 123 | Abscess | 14 | 3.3 | 3.3 | signal |
| 124 | Dysarthria | 33 | 3.3 | 3.3 | signal |
| 125 | Retinal Detachment | 8 | 3.2 | 3.2 | signal |
| 126 | Renal Injury | 26 | 3.2 | 3.2 | signal |
| 127 | Ventricular Extrasystoles | 9 | 3.2 | 3.2 | signal |
| 128 | Drug Effective For Unapproved Indication | 25 | 3.2 | 3.2 | signal |
| 129 | Splenomegaly | 10 | 3.2 | 3.2 | signal |
| 130 | Dysstasia | 25 | 3.2 | 3.2 | signal |
| 131 | Blood Triglycerides Increased | 15 | 3.1 | 3.2 | signal |
| 132 | Economic Problem | 13 | 3.1 | 3.1 | signal |
| 133 | Blood Potassium Decreased | 25 | 3.1 | 3.1 | signal |
| 134 | Anhedonia | 22 | 3.1 | 3.1 | signal |
| 135 | Hypophagia | 21 | 3.1 | 3.1 | signal |
| 136 | Sinus Bradycardia | 8 | 3.1 | 3.1 | signal |
| 137 | Product Administered At Inappropriate Site | 15 | 3.1 | 3.1 | signal |
| 138 | Mental Impairment | 20 | 3.1 | 3.1 | signal |
| 139 | Brain Fog | 12 | 3.1 | 3.1 | signal |
| 140 | Haemorrhoids | 16 | 3.0 | 3.1 | signal |
| 141 | Hypercalcaemia | 10 | 3.0 | 3.0 | signal |
| 142 | Bradycardia | 43 | 3.0 | 3.0 | signal |
| 143 | Sinus Disorder | 16 | 3.0 | 3.0 | signal |
| 144 | Neurotoxicity | 14 | 3.0 | 3.0 | signal |
| 145 | Feeding Disorder | 16 | 3.0 | 3.0 | signal |
| 146 | Eye Infection | 9 | 3.0 | 3.0 | signal |
| 147 | Orthostatic Hypotension | 14 | 3.0 | 3.0 | signal |
| 148 | Drug Withdrawal Syndrome | 71 | 3.0 | 3.0 | signal |
| 149 | Drug Intolerance | 77 | 3.0 | 3.0 | signal |
| 150 | Drug Toxicity | 11 | 3.0 | 3.0 | signal |
| 151 | Respiratory Failure | 58 | 3.0 | 3.0 | signal |
| 152 | Metastases To Bone | 13 | 3.0 | 3.0 | signal |
| 153 | Rebound Effect | 9 | 3.0 | 3.0 | signal |
| 154 | Cholecystectomy | 9 | 2.9 | 2.9 | signal |
| 155 | Serotonin Syndrome | 15 | 2.9 | 2.9 | signal |
| 156 | Post Procedural Complication | 15 | 2.9 | 2.9 | signal |
| 157 | Intervertebral Disc Protrusion | 17 | 2.9 | 2.9 | signal |
| 158 | Blood Bilirubin Increased | 21 | 2.9 | 2.9 | signal |
| 159 | Impaired Quality Of Life | 11 | 2.8 | 2.8 | signal |
| 160 | Thrombocytopenia | 85 | 2.8 | 2.9 | signal |
| 161 | Cholecystitis | 9 | 2.8 | 2.8 | signal |
| 162 | Muscle Rigidity | 9 | 2.8 | 2.8 | signal |
| 163 | Hepatic Steatosis | 14 | 2.8 | 2.8 | signal |
| 164 | Flank Pain | 7 | 2.8 | 2.8 | signal |
| 165 | Altered State Of Consciousness | 16 | 2.8 | 2.8 | signal |
| 166 | Neutrophil Count Decreased | 30 | 2.8 | 2.8 | signal |
| 167 | Pericardial Effusion | 17 | 2.7 | 2.8 | signal |
| 168 | Ocular Discomfort | 8 | 2.7 | 2.7 | signal |
| 169 | Injury | 52 | 2.7 | 2.8 | signal |
| 170 | Posterior Reversible Encephalopathy Syndrome | 7 | 2.7 | 2.7 | signal |
| 171 | Encephalopathy | 18 | 2.7 | 2.7 | signal |
| 172 | Generalised Tonic-clonic Seizure | 12 | 2.7 | 2.7 | signal |
| 173 | Product Use In Unapproved Indication | 179 | 2.7 | 2.8 | signal |
| 174 | Contraindicated Product Administered | 22 | 2.7 | 2.7 | signal |
| 175 | Thirst | 13 | 2.7 | 2.7 | signal |
| 176 | Hypomagnesaemia | 10 | 2.7 | 2.7 | signal |
| 177 | Renal Failure Acute | 31 | 2.7 | 2.7 | signal |
| 178 | Dystonia | 14 | 2.7 | 2.7 | signal |
| 179 | Leukocytosis | 13 | 2.7 | 2.7 | signal |
| 180 | Gastroenteritis Viral | 13 | 2.7 | 2.7 | signal |
| 181 | Hyponatraemia | 40 | 2.6 | 2.7 | signal |
| 182 | Hospice Care | 7 | 2.6 | 2.6 | signal |
| 183 | Ligament Sprain | 7 | 2.6 | 2.6 | signal |
| 184 | Hemiparesis | 12 | 2.6 | 2.6 | signal |
| 185 | Eating Disorder | 15 | 2.6 | 2.6 | signal |
| 186 | Hypersomnia | 20 | 2.6 | 2.6 | signal |
| 187 | Motor Dysfunction | 7 | 2.6 | 2.6 | signal |
| 188 | Blood Sodium Decreased | 13 | 2.6 | 2.6 | signal |
| 189 | Eye Pain | 38 | 2.6 | 2.6 | signal |
| 190 | Somnolence | 138 | 2.6 | 2.6 | signal |
| 191 | Off Label Use | 594 | 2.5 | 2.7 | signal |
| 192 | Metastases To Liver | 12 | 2.5 | 2.5 | signal |
| 193 | Body Temperature Increased | 14 | 2.5 | 2.5 | signal |
| 194 | Visual Impairment | 84 | 2.5 | 2.6 | signal |
| 195 | Head Discomfort | 12 | 2.5 | 2.5 | signal |
| 196 | Seizure | 78 | 2.5 | 2.5 | signal |
| 197 | Limb Discomfort | 21 | 2.5 | 2.5 | signal |
| 198 | Lethargy | 39 | 2.5 | 2.5 | signal |
| 199 | Urinary Incontinence | 20 | 2.5 | 2.5 | signal |
| 200 | Weight Fluctuation | 7 | 2.5 | 2.5 | signal |
| 201 | Tenderness | 7 | 2.5 | 2.5 | signal |
| 202 | Coagulopathy | 11 | 2.5 | 2.5 | signal |
| 203 | Viral Infection | 22 | 2.5 | 2.5 | signal |
| 204 | Glomerular Filtration Rate Decreased | 8 | 2.5 | 2.5 | signal |
| 205 | Heart Rate Irregular | 15 | 2.5 | 2.5 | signal |
| 206 | Urinary Tract Infection | 112 | 2.4 | 2.5 | signal |
| 207 | Hypersensitivity | 122 | 2.4 | 2.5 | signal |
| 208 | Cystitis | 21 | 2.4 | 2.4 | signal |
| 209 | Decreased Activity | 7 | 2.4 | 2.4 | signal |
| 210 | Bone Disorder | 12 | 2.4 | 2.4 | signal |
| 211 | Heart Rate Decreased | 23 | 2.4 | 2.4 | signal |
| 212 | End Stage Renal Disease | 12 | 2.4 | 2.4 | signal |
| 213 | Generalised Oedema | 8 | 2.4 | 2.4 | signal |
| 214 | Pharyngitis Streptococcal | 7 | 2.4 | 2.4 | signal |
| 215 | Dementia | 18 | 2.4 | 2.4 | signal |
| 216 | Cardiomegaly | 8 | 2.4 | 2.4 | signal |
| 217 | Stomatitis | 39 | 2.4 | 2.4 | signal |
| 218 | Blood Creatinine Increased | 42 | 2.4 | 2.4 | signal |
| 219 | Cardio-respiratory Arrest | 27 | 2.4 | 2.4 | signal |
| 220 | Skin Reaction | 9 | 2.4 | 2.4 | signal |
| 221 | Brain Oedema | 8 | 2.4 | 2.4 | signal |
| 222 | Hyperglycaemia | 23 | 2.4 | 2.4 | signal |
| 223 | Anxiety | 179 | 2.3 | 2.4 | signal |
| 224 | Sleep Apnoea Syndrome | 12 | 2.3 | 2.3 | signal |
| 225 | Infusion Site Pain | 8 | 2.3 | 2.3 | signal |
| 226 | Paralysis | 9 | 2.3 | 2.3 | signal |
| 227 | Inappropriate Schedule Of Drug Administration | 45 | 2.3 | 2.3 | signal |
| 228 | Cognitive Disorder | 29 | 2.3 | 2.3 | signal |
| 229 | Intraocular Pressure Increased | 8 | 2.3 | 2.3 | signal |
| 230 | Rash Erythematous | 29 | 2.3 | 2.3 | signal |
| 231 | Bronchitis | 46 | 2.3 | 2.3 | signal |
| 232 | Ear Pain | 12 | 2.3 | 2.3 | signal |
| 233 | Cardiac Arrest | 51 | 2.3 | 2.3 | signal |
| 234 | Feeling Abnormal | 148 | 2.3 | 2.3 | signal |
| 235 | Gallbladder Disorder | 11 | 2.3 | 2.3 | signal |
| 236 | Decreased Immune Responsiveness | 6 | 2.3 | 2.3 | no signal |
| 237 | Mucosal Inflammation | 16 | 2.3 | 2.3 | signal |
| 238 | Nodule | 8 | 2.3 | 2.3 | signal |
| 239 | Migraine | 58 | 2.3 | 2.3 | signal |
| 240 | Drug Interaction | 97 | 2.3 | 2.3 | signal |
| 241 | Renal Tubular Necrosis | 6 | 2.3 | 2.3 | no signal |
| 242 | Pancytopenia | 34 | 2.3 | 2.3 | signal |
| 243 | Hepatomegaly | 6 | 2.3 | 2.3 | no signal |
| 244 | Metastases To Lung | 7 | 2.3 | 2.3 | no signal |
| 245 | Muscle Twitching | 14 | 2.3 | 2.3 | signal |
| 246 | Constipation | 130 | 2.2 | 2.3 | signal |
| 247 | Wrong Technique In Product Usage Process | 121 | 2.2 | 2.3 | signal |
| 248 | Taste Disorder | 12 | 2.2 | 2.2 | signal |
| 249 | Dry Eye | 29 | 2.2 | 2.2 | signal |
| 250 | Stress | 43 | 2.2 | 2.2 | signal |
| 251 | Cellulitis | 30 | 2.2 | 2.2 | signal |
| 252 | Red Blood Cell Count Decreased | 17 | 2.2 | 2.2 | signal |
| 253 | Pneumonitis | 16 | 2.2 | 2.2 | signal |
| 254 | Coma | 28 | 2.2 | 2.2 | signal |
| 255 | Alanine Aminotransferase Increased | 36 | 2.2 | 2.2 | signal |
| 256 | Abdominal Pain | 136 | 2.2 | 2.2 | signal |
| 257 | Rib Fracture | 12 | 2.2 | 2.2 | signal |
| 258 | Hypocalcaemia | 11 | 2.2 | 2.2 | signal |
| 259 | Platelet Count Decreased | 62 | 2.2 | 2.2 | signal |
| 260 | Pulmonary Oedema | 26 | 2.2 | 2.2 | signal |
| 261 | Oral Pain | 13 | 2.2 | 2.2 | signal |
| 262 | Foot Fracture | 11 | 2.2 | 2.2 | signal |
| 263 | Renal Failure | 77 | 2.1 | 2.2 | signal |
| 264 | Nervous System Disorder | 18 | 2.1 | 2.1 | signal |
| 265 | Headache | 358 | 2.1 | 2.2 | signal |
| 266 | Lung Infection | 9 | 2.1 | 2.1 | signal |
| 267 | Gastritis | 15 | 2.1 | 2.1 | signal |
| 268 | Transfusion | 6 | 2.1 | 2.1 | no signal |
| 269 | Fluid Retention | 29 | 2.1 | 2.1 | signal |
| 270 | Malaise | 250 | 2.1 | 2.2 | signal |
| 271 | Blindness Unilateral | 8 | 2.1 | 2.1 | no signal |
| 272 | Secretion Discharge | 7 | 2.1 | 2.1 | no signal |
| 273 | No Therapeutic Response | 7 | 2.1 | 2.1 | no signal |
| 274 | Ear Infection | 15 | 2.1 | 2.1 | signal |
| 275 | Blood Lactate Dehydrogenase Increased | 9 | 2.1 | 2.1 | signal |
| 276 | Pain In Jaw | 16 | 2.1 | 2.1 | signal |
| 277 | Hypotension | 113 | 2.1 | 2.1 | signal |
| 278 | Sudden Death | 6 | 2.1 | 2.1 | no signal |
| 279 | Blood Pressure Decreased | 37 | 2.1 | 2.1 | signal |
| 280 | Decreased Appetite | 129 | 2.1 | 2.1 | signal |
| 281 | Palmar-plantar Erythrodysaesthesia Syndrome | 13 | 2.1 | 2.1 | signal |
| 282 | Tremor | 92 | 2.1 | 2.1 | signal |
| 283 | White Blood Cell Count Decreased | 60 | 2.1 | 2.1 | signal |
| 284 | Wound Infection | 6 | 2.1 | 2.1 | no signal |
| 285 | Mental Disorder | 24 | 2.0 | 2.1 | signal |
| 286 | Crying | 20 | 2.0 | 2.0 | signal |
| 287 | Panic Attack | 20 | 2.0 | 2.0 | signal |
| 288 | Adverse Drug Reaction | 49 | 2.0 | 2.0 | signal |
| 289 | Photosensitivity Reaction | 9 | 2.0 | 2.0 | no signal |
| 290 | Drug Administration Error | 17 | 2.0 | 2.0 | signal |
| 291 | Loss Of Consciousness | 70 | 2.0 | 2.0 | signal |
| 292 | Skin Irritation | 25 | 2.0 | 2.0 | signal |
| 293 | Tinnitus | 25 | 2.0 | 2.0 | signal |
| 294 | Ventricular Tachycardia | 9 | 2.0 | 2.0 | no signal |
| 295 | Unevaluable Event | 41 | 2.0 | 2.0 | signal |
| 296 | Neoplasm Progression | 19 | 2.0 | 2.0 | signal |
| 297 | Oropharyngeal Pain | 50 | 2.0 | 2.0 | signal |
| 298 | Nerve Injury | 6 | 2.0 | 2.0 | no signal |
| 299 | Plasma Cell Myeloma | 21 | 2.0 | 2.0 | no signal |
| 300 | Anorexia | 7 | 2.0 | 2.0 | no signal |
| 301 | Product Availability Issue | 12 | 2.0 | 2.0 | no signal |
| 302 | Intestinal Perforation | 6 | 2.0 | 2.0 | no signal |
| 303 | Tubulointerstitial Nephritis | 10 | 2.0 | 2.0 | no signal |
| 304 | Fistula | 6 | 2.0 | 2.0 | no signal |
| 305 | Toxic Epidermal Necrolysis | 8 | 2.0 | 2.0 | no signal |
| 306 | Status Epilepticus | 6 | 2.0 | 2.0 | no signal |
| 307 | Sputum Discoloured | 5 | 2.0 | 2.0 | no signal |
| 308 | Electrocardiogram Qt Prolonged | 19 | 2.0 | 2.0 | no signal |
| 309 | Haemoglobin Decreased | 54 | 2.0 | 2.0 | no signal |
| 310 | Nephrolithiasis | 24 | 2.0 | 2.0 | no signal |
| 311 | Joint Range Of Motion Decreased | 7 | 1.9 | 1.9 | no signal |
| 312 | Cholestasis | 10 | 1.9 | 1.9 | no signal |
| 313 | Malignant Melanoma | 7 | 1.9 | 1.9 | no signal |
| 314 | Hyperhidrosis | 67 | 1.9 | 1.9 | no signal |
| 315 | Memory Impairment | 71 | 1.9 | 1.9 | no signal |
| 316 | Product Use Complaint | 8 | 1.9 | 1.9 | no signal |
| 317 | Poor Quality Sleep | 11 | 1.9 | 1.9 | no signal |
| 318 | Acute Myeloid Leukaemia | 8 | 1.9 | 1.9 | no signal |
| 319 | Gait Inability | 17 | 1.9 | 1.9 | no signal |
| 320 | Vitreous Floaters | 5 | 1.9 | 1.9 | no signal |
| 321 | Drug Prescribing Error | 10 | 1.9 | 1.9 | no signal |
| 322 | Pharyngeal Oedema | 8 | 1.9 | 1.9 | no signal |
| 323 | Fall | 170 | 1.9 | 1.9 | no signal |
| 324 | Wheezing | 30 | 1.9 | 1.9 | no signal |
| 325 | Central Nervous System Lesion | 7 | 1.9 | 1.9 | no signal |
| 326 | Deep Vein Thrombosis | 33 | 1.9 | 1.9 | no signal |
| 327 | Blood Pressure Abnormal | 10 | 1.9 | 1.9 | no signal |
| 328 | Pulmonary Embolism | 48 | 1.9 | 1.9 | no signal |
| 329 | Bladder Disorder | 5 | 1.9 | 1.9 | no signal |
| 330 | Paraesthesia | 79 | 1.9 | 1.9 | no signal |
| 331 | Toxicity To Various Agents | 84 | 1.9 | 1.9 | no signal |
| 332 | Premature Delivery | 8 | 1.9 | 1.9 | no signal |
| 333 | Blister | 28 | 1.9 | 1.9 | no signal |
| 334 | Drug Effect Less Than Expected | 7 | 1.8 | 1.8 | no signal |
| 335 | Hepatotoxicity | 11 | 1.8 | 1.8 | no signal |
| 336 | Movement Disorder | 16 | 1.8 | 1.8 | no signal |
| 337 | Chronic Kidney Disease | 38 | 1.8 | 1.8 | no signal |
| 338 | Transaminases Increased | 11 | 1.8 | 1.8 | no signal |
| 339 | Fibromyalgia | 12 | 1.8 | 1.8 | no signal |
| 340 | Emphysema | 5 | 1.8 | 1.8 | no signal |
| 341 | Incorrect Product Administration Duration | 10 | 1.8 | 1.8 | no signal |
| 342 | Blindness | 20 | 1.8 | 1.8 | no signal |
| 343 | Initial Insomnia | 5 | 1.8 | 1.8 | no signal |
| 344 | Chest Discomfort | 50 | 1.8 | 1.8 | no signal |
| 345 | Neutropenia | 66 | 1.8 | 1.8 | no signal |
| 346 | Hyperkalaemia | 17 | 1.8 | 1.8 | no signal |
| 347 | Hyperbilirubinaemia | 5 | 1.8 | 1.8 | no signal |
| 348 | Middle Insomnia | 9 | 1.8 | 1.8 | no signal |
| 349 | Myelodysplastic Syndrome | 7 | 1.8 | 1.8 | no signal |
| 350 | Intentional Product Misuse | 42 | 1.8 | 1.8 | no signal |
| 351 | Frequent Bowel Movements | 13 | 1.8 | 1.8 | no signal |
| 352 | Surgery | 28 | 1.8 | 1.8 | no signal |
| 353 | Hepatic Cirrhosis | 9 | 1.8 | 1.8 | no signal |
| 354 | Visual Acuity Reduced | 16 | 1.8 | 1.8 | no signal |
| 355 | Muscle Atrophy | 6 | 1.8 | 1.8 | no signal |
| 356 | Face Oedema | 8 | 1.8 | 1.8 | no signal |
| 357 | Lacrimation Increased | 14 | 1.7 | 1.7 | no signal |
| 358 | Glaucoma | 9 | 1.7 | 1.7 | no signal |
| 359 | Convulsion | 27 | 1.7 | 1.7 | no signal |
| 360 | Body Height Decreased | 5 | 1.7 | 1.7 | no signal |
| 361 | Leukopenia | 23 | 1.7 | 1.7 | no signal |
| 362 | Platelet Count Increased | 6 | 1.7 | 1.7 | no signal |
| 363 | Kidney Infection | 9 | 1.7 | 1.7 | no signal |
| 364 | Dysmenorrhoea | 6 | 1.7 | 1.7 | no signal |
| 365 | Blood Pressure Fluctuation | 11 | 1.7 | 1.7 | no signal |
| 366 | Gastrointestinal Pain | 5 | 1.7 | 1.7 | no signal |
| 367 | Depressed Level Of Consciousness | 18 | 1.7 | 1.7 | no signal |
| 368 | Complication Associated With Device | 6 | 1.7 | 1.7 | no signal |
| 369 | Cold Sweat | 8 | 1.7 | 1.7 | no signal |
| 370 | Adverse Reaction | 6 | 1.7 | 1.7 | no signal |
| 371 | Malignant Neoplasm Progression | 46 | 1.7 | 1.7 | no signal |
| 372 | International Normalised Ratio Increased | 13 | 1.7 | 1.7 | no signal |
| 373 | Product Use Issue | 84 | 1.7 | 1.7 | no signal |
| 374 | Throat Irritation | 20 | 1.7 | 1.7 | no signal |
| 375 | Jaundice | 12 | 1.7 | 1.7 | no signal |
| 376 | Palpitations | 52 | 1.7 | 1.7 | no signal |
| 377 | Ill-defined Disorder | 27 | 1.7 | 1.7 | no signal |
| 378 | Osteonecrosis Of Jaw | 11 | 1.6 | 1.6 | no signal |
| 379 | Respiratory Tract Congestion | 7 | 1.6 | 1.6 | no signal |
| 380 | Pallor | 12 | 1.6 | 1.6 | no signal |
| 381 | Ageusia | 11 | 1.6 | 1.6 | no signal |
| 382 | Illness | 44 | 1.6 | 1.6 | no signal |
| 383 | Drug Hypersensitivity | 85 | 1.6 | 1.6 | no signal |
| 384 | Emotional Distress | 53 | 1.6 | 1.6 | no signal |
| 385 | Pancreatitis | 23 | 1.6 | 1.6 | no signal |
| 386 | Sensory Disturbance | 7 | 1.6 | 1.6 | no signal |
| 387 | Agranulocytosis | 8 | 1.6 | 1.6 | no signal |
| 388 | Respiratory Arrest | 12 | 1.6 | 1.6 | no signal |
| 389 | Device Occlusion | 6 | 1.6 | 1.6 | no signal |
| 390 | Oral Discomfort | 6 | 1.6 | 1.6 | no signal |
| 391 | Influenza | 48 | 1.6 | 1.6 | no signal |
| 392 | Back Disorder | 7 | 1.6 | 1.6 | no signal |
| 393 | Post Procedural Haemorrhage | 5 | 1.6 | 1.6 | no signal |
| 394 | Eye Disorder | 14 | 1.6 | 1.6 | no signal |
| 395 | Diarrhoea Haemorrhagic | 4 | 1.6 | 1.6 | no signal |
| 396 | Thinking Abnormal | 8 | 1.6 | 1.6 | no signal |
| 397 | Spinal Pain | 5 | 1.6 | 1.6 | no signal |
| 398 | Skin Fissures | 8 | 1.6 | 1.6 | no signal |
| 399 | Drug Level Increased | 7 | 1.6 | 1.6 | no signal |
| 400 | Hepatocellular Injury | 6 | 1.6 | 1.6 | no signal |
| 401 | Arrhythmia | 20 | 1.6 | 1.6 | no signal |
| 402 | Psychomotor Hyperactivity | 7 | 1.6 | 1.6 | no signal |
| 403 | Laceration | 4 | 1.6 | 1.6 | no signal |
| 404 | Nervousness | 22 | 1.6 | 1.6 | no signal |
| 405 | Hernia | 8 | 1.5 | 1.5 | no signal |
| 406 | Medication Error | 23 | 1.5 | 1.5 | no signal |
| 407 | Schizophrenia | 5 | 1.5 | 1.5 | no signal |
| 408 | Sneezing | 9 | 1.5 | 1.5 | no signal |
| 409 | Overdose | 87 | 1.5 | 1.5 | no signal |
| 410 | Haemorrhage Intracranial | 6 | 1.5 | 1.5 | no signal |
| 411 | Helicobacter Infection | 4 | 1.5 | 1.5 | no signal |
| 412 | Poor Venous Access | 4 | 1.4 | 1.4 | no signal |
| 413 | Folliculitis | 4 | 1.4 | 1.4 | no signal |
| 414 | Scratch | 4 | 1.4 | 1.4 | no signal |
| 415 | Tooth Loss | 8 | 1.4 | 1.4 | no signal |
| 416 | Suicidal Ideation | 35 | 1.4 | 1.4 | no signal |
| 417 | Product Prescribing Error | 9 | 1.4 | 1.4 | no signal |
| 418 | Eye Swelling | 14 | 1.4 | 1.4 | no signal |
| 419 | Eczema | 19 | 1.4 | 1.4 | no signal |
| 420 | Asthma | 41 | 1.4 | 1.4 | no signal |
| 421 | Mania | 6 | 1.4 | 1.4 | no signal |
| 422 | Ocular Hyperaemia | 17 | 1.4 | 1.4 | no signal |
| 423 | Abnormal Dreams | 10 | 1.3 | 1.3 | no signal |
| 424 | Exposure During Pregnancy | 22 | 1.3 | 1.3 | no signal |
| 425 | Anger | 12 | 1.3 | 1.3 | no signal |
| 426 | Anaphylactic Shock | 9 | 1.3 | 1.3 | no signal |
| 427 | Full Blood Count Decreased | 7 | 1.3 | 1.3 | no signal |
| 428 | Hot Flush | 26 | 1.3 | 1.3 | no signal |
| 429 | Gastrointestinal Haemorrhage | 29 | 1.3 | 1.3 | no signal |
| 430 | Lactic Acidosis | 11 | 1.3 | 1.3 | no signal |
| 431 | Bone Marrow Failure | 7 | 1.3 | 1.3 | no signal |
| 432 | Product Dose Omission In Error | 9 | 1.2 | 1.2 | no signal |
| 433 | Colon Cancer | 5 | 1.2 | 1.2 | no signal |
| 434 | Hospitalisation | 51 | 1.2 | 1.2 | no signal |
| 435 | Spinal Operation | 4 | 1.2 | 1.2 | no signal |
| 436 | Accidental Overdose | 12 | 1.2 | 1.2 | no signal |
| 437 | Respiratory Depression | 4 | 1.2 | 1.2 | no signal |
| 438 | Blood Thyroid Stimulating Hormone Increased | 3 | 1.2 | 1.2 | no signal |
| 439 | Dysgeusia | 24 | 1.2 | 1.2 | no signal |
| 440 | Hair Colour Changes | 4 | 1.2 | 1.2 | no signal |
| 441 | Tardive Dyskinesia | 9 | 1.2 | 1.2 | no signal |
| 442 | Colitis Ulcerative | 14 | 1.2 | 1.2 | no signal |
| 443 | Drug Dependence | 51 | 1.2 | 1.2 | no signal |
| 444 | Inappropriate Schedule Of Product Administration | 55 | 1.2 | 1.2 | no signal |
| 445 | Accidental Exposure To Product | 31 | 1.2 | 1.2 | no signal |
| 446 | Knee Operation | 3 | 1.1 | 1.1 | no signal |
| 447 | Osteonecrosis | 10 | 1.1 | 1.1 | no signal |
| 448 | Vaginal Discharge | 3 | 1.1 | 1.1 | no signal |
| 449 | Injury Associated With Device | 6 | 1.1 | 1.1 | no signal |
| 450 | Multiple Sclerosis Relapse | 20 | 1.1 | 1.1 | no signal |
| 451 | Death | 249 | 1.1 | 1.1 | no signal |
| 452 | Skin Exfoliation | 24 | 1.1 | 1.1 | no signal |
| 453 | Cerebrovascular Accident | 49 | 1.1 | 1.1 | no signal |
| 454 | Hereditary Angioedema | 3 | 1.1 | 1.1 | no signal |
| 455 | Device Leakage | 12 | 1.1 | 1.1 | no signal |
| 456 | Dry Skin | 37 | 1.0 | 1.0 | no signal |
| 457 | Skin Cancer | 6 | 1.0 | 1.0 | no signal |
| 458 | Anosmia | 4 | 1.0 | 1.0 | no signal |
| 459 | Product Packaging Quantity Issue | 3 | 1.0 | 1.0 | no signal |
| 460 | Pulmonary Arterial Hypertension | 4 | 1.0 | 1.0 | no signal |
| 461 | Cardiovascular Disorder | 7 | 1.0 | 1.0 | no signal |
| 462 | Expired Product Administered | 9 | 1.0 | 1.0 | no signal |
| 463 | Circumstance Or Information Capable Of Leading To Medication Error | 9 | 1.0 | 1.0 | no signal |
| 464 | Lung Neoplasm Malignant | 11 | 1.0 | 1.0 | no signal |
| 465 | Pain Of Skin | 7 | 1.0 | 1.0 | no signal |
| 466 | Aggression | 13 | 1.0 | 1.0 | no signal |
| 467 | Menorrhagia | 5 | 0.9 | 0.9 | no signal |
| 468 | Product Physical Issue | 5 | 0.9 | 0.9 | no signal |
| 469 | Intentional Self-injury | 5 | 0.9 | 0.9 | no signal |
| 470 | Device Defective | 4 | 0.9 | 0.9 | no signal |
| 471 | Injection Site Discolouration | 3 | 0.9 | 0.9 | no signal |
| 472 | Peritonitis | 5 | 0.9 | 0.9 | no signal |
| 473 | Extrapyramidal Disorder | 6 | 0.9 | 0.9 | no signal |
| 474 | Poisoning | 3 | 0.9 | 0.9 | no signal |
| 475 | Metrorrhagia | 4 | 0.9 | 0.9 | no signal |
| 476 | Blood Glucose Decreased | 11 | 0.8 | 0.8 | no signal |
| 477 | Extra Dose Administered | 9 | 0.8 | 0.8 | no signal |
| 478 | Abortion Spontaneous | 9 | 0.8 | 0.8 | no signal |
| 479 | Suicide Attempt | 13 | 0.8 | 0.8 | no signal |
| 480 | Incorrect Dose Administered | 47 | 0.8 | 0.8 | no signal |
| 481 | Product Substitution Issue | 12 | 0.8 | 0.8 | no signal |
| 482 | Gastric Cancer | 5 | 0.7 | 0.7 | no signal |
| 483 | Sickle Cell Anaemia With Crisis | 3 | 0.7 | 0.7 | no signal |
| 484 | Bone Density Decreased | 6 | 0.7 | 0.7 | no signal |
| 485 | Intentional Drug Misuse | 4 | 0.7 | 0.7 | no signal |
| 486 | Acne | 14 | 0.7 | 0.7 | no signal |
| 487 | Drug Effect Decreased | 10 | 0.7 | 0.7 | no signal |
| 488 | Amenorrhoea | 3 | 0.7 | 0.7 | no signal |
| 489 | Vaginal Haemorrhage | 7 | 0.6 | 0.6 | no signal |
| 490 | Device Dislocation | 7 | 0.6 | 0.6 | no signal |
| 491 | Pharmaceutical Product Complaint | 4 | 0.6 | 0.6 | no signal |
| 492 | Device Issue | 13 | 0.6 | 0.6 | no signal |
| 493 | Device Use Error | 5 | 0.5 | 0.5 | no signal |
| 494 | Skin Burning Sensation | 10 | 0.5 | 0.5 | no signal |
| 495 | Needle Issue | 4 | 0.5 | 0.5 | no signal |
| 496 | Pancreatic Carcinoma | 4 | 0.5 | 0.5 | no signal |
| 497 | Breast Cancer | 12 | 0.5 | 0.5 | no signal |
| 498 | Product Storage Error | 10 | 0.4 | 0.4 | no signal |
| 499 | Incorrect Route Of Drug Administration | 4 | 0.4 | 0.4 | no signal |
| 500 | Completed Suicide | 9 | 0.4 | 0.4 | no signal |
| 501 | Dermatitis Atopic | 5 | 0.4 | 0.4 | no signal |
| 502 | Drug Abuse | 7 | 0.3 | 0.3 | no signal |
| 503 | Device Breakage | 3 | 0.3 | 0.3 | no signal |
| 504 | Prostate Cancer | 6 | 0.3 | 0.3 | no signal |
| 505 | Wrong Technique In Device Usage Process | 3 | 0.2 | 0.2 | no signal |
| 506 | Renal Cancer | 3 | 0.2 | 0.2 | no signal |
| 507 | Dependence | 3 | 0.2 | 0.2 | no signal |